Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations 22805 

inspections and examinations in 

connection with preclearing passengers, 

crew, and their goods bound for the 

United States. Generally, travelers who 

are inspected at a preclearance facility 

are permitted to arrive at a U.S. 

domestic facility and exit the U.S. 

domestic terminal upon arrival or 

connect directly to a U.S. domestic 

flight without further CBP processing. 

Preclearance facilities primarily serve to 

facilitate low risk travelers, relieve 

passenger congestion at federal 

inspection facilities in the United 

States, and enhance security in the air 

environment through the screening and 

inspection of travelers prior to their 

arrival in the United States. In Fiscal 

Year 2010, over 14 million aircraft 

travelers were processed at preclearance 

locations. This figure represents more 

than 16 percent of all commercial 

aircraft travelers cleared by CBP in FY 

2010. 

The Agreement Between the 

Government of the United States of 

America and the Government of Ireland 

on Air Transport Preclearance was 

signed on November 17, 2008. 

Preclearance operations began in 

Dublin, Ireland on January 19, 2011. 

The Dublin preclearance station is open 

for use by commercial flights. 

Section 101.5 of the CBP regulations 

(19 CFR 101.5) sets forth a list of CBP 

preclearance offices in foreign countries. 

This document amends this section to 

add Dublin, Ireland to the list of 

preclearance offices. 

Inapplicability of Public Notice and 

Delayed Effective Date Requirements 

This amendment reflects the addition 

of a new CBP preclearance office that 

was established through a signed 

agreement between the United States 

and the Government of Ireland. 

Accordingly, pursuant to 5 U.S.C. 

553(b)(B), notice and public procedure 

are unnecessary. For the same reason, 

pursuant to 5 U.S.C. 553(d)(3), a delayed 

effective date is not required. 

The Regulatory Flexibility Act and 

Executive Order 12866 

Because no notice of proposed 

rulemaking is required, the provisions 

of the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) do not apply. This 

amendment does not meet the criteria 

for a ‘‘significant regulatory action’’ as 

specified in Executive Order 12866. 

Signing Authority 

This document is being issued in 

accordance with 19 CFR 0.2(a). 

List of Subjects in 19 CFR Part 101 

Customs duties and inspection, 

Customs ports of entry, Foreign trade 

statistics, Imports, Organization and 

functions (Government agencies), 

Shipments, Vessels. 

Amendments to Regulations 

For the reasons set forth above, Part 

101 of the Code of Federal Regulations 

(19 CFR part 101), is amended as set 

forth below. 

PART 101—GENERAL PROVISIONS 

■ 1. The general authority citation for 

part 101 and the specific authority 

citation for section 101.5 continue to 

read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 2, 66, 

1202 (General Note 3(i), Harmonized Tariff 

Schedule of the United States), 1623, 1624, 

1646a. 

* * * * * 

Section 101.5 also issued under 19 U.S.C. 

1629. 

* * * * * 

■ 2. Revise § 101.5 to read as follows: 

§ 101.5 CBP preclearance offices in 

foreign countries. 

Listed below are the preclearance 

offices in foreign countries where CBP 

officers are located. A Director, 

Preclearance, located in the Office of 

Field Operations at CBP Headquarters, 

is the responsible CBP officer exercising 

supervisory control over all 

preclearance offices. 

Country CBP office 

Aruba ............ Orangestad. 

The Bahamas Freeport. 

Nassau. 

Bermuda ....... Kindley Field. 

Canada ......... Calgary, Alberta. 

Edmonton, Alberta. 

Halifax, Nova Scotia. 

Montreal, Quebec. 

Ottawa, Ontario. 

Toronto, Ontario. 

Vancouver, British Columbia. 

Winnipeg, Manitoba. 

Ireland .......... Dublin. 

Shannon. 

Dated: February 11, 2011. 

Alan D. Bersin, 

Commissioner, U.S. Customs and Border 

Protection. 

[FR Doc. 2011–9883 Filed 4–22–11; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2006–N–0045] (Formerly 

Docket No. 2006N–0109) 

Medical Devices; Reclassification of 

the Topical Oxygen Chamber for 

Extremities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is reclassifying 

the topical oxygen chamber for 

extremities (TOCE) from class III to class 

II. This device is intended to surround 

a patient’s limb and apply humidified 

oxygen topically at a pressure slightly 

greater than atmospheric pressure to aid 

healing of chronic skin ulcers, such as 

bedsores. This reclassification is on the 

Secretary of Health and Human 

Services’s own initiative based on new 

information. This action is being taken 

under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

Amendments), the Safe Medical Devices 

Act of 1990 (the SMDA), and the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA). Elsewhere in this 

issue of the Federal Register, FDA is 

announcing the availability of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Topical Oxygen Chamber for 

Extremities,’’ which will serve as the 

special control for this device. 

DATES: This rule is effective May 25, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Charles N. Durfor, Center for Devices 

and Radiological Health (HFZ–410), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3555. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The FD&C Act (21 U.S.C. 301 et seq.), 

as amended by the 1976 Amendments 

(Pub. L. 94–295), the SMDA (Pub. L. 

101–629), and the FDAMA (Pub. L. 105– 

115), established a comprehensive 

system for the regulation of medical 

devices intended for human use. 

Section 513 of the FD&C Act (21 U.S.C. 

360c) established three categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 


jdjones on DSKHWCL6B1PROD with RULES
22806 Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513 of the FD&C Act, 

devices that were in commercial 

distribution before May 28, 1976 (the 

date of enactment of the 1976 

Amendments), generally referred to as 

preamendments devices, are classified 

after FDA has: (1) Received a 

recommendation from a device 

classification panel (an FDA advisory 

committee); (2) published the panel’s 

recommendation for comment, along 

with a proposed regulation classifying 

the device; and (3) published a final 

regulation classifying the device. FDA 

has classified most preamendments 

devices under these procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976, 

generally referred to as postamendments 

devices, are classified automatically by 

statute (section 513(f) of the FD&C Act 

(21 U.S.C. 360c(f)) into class III without 

any FDA rulemaking process. 

Postamendment devices remain in class 

III and require premarket approval, 

unless the device is reclassified into 

class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act (21 U.S.C. 

360c(i)), to a predicate device that does 

not require premarket approval. The 

agency determines whether new devices 

are substantially equivalent to predicate 

devices by means of premarket 

notification procedures in section 510(k) 

of the FD&C Act (21 U.S.C. 360(k)) and 

part 807 of the regulations (21 CFR part 

807). 

A preamendments device that has 

been classified into class III may be 

marketed, by means of premarket 

notification procedures, without 

submission of a premarket approval 

application (PMA) until FDA issues a 

final regulation under section 515(b) of 

the FD&C Act (21 U.S.C. 360e(b)) 

requiring premarket approval. 

Section 513(e) of the FD&C Act (21 

U.S.C. 360c(e)) governs reclassification 

of classified preamendments devices. 

This section provides that FDA may, by 

rulemaking, reclassify a device based 

upon ‘‘new information.’’ FDA can 

initiate a reclassification under section 

513(e) of the FD&C Act or an interested 

person may petition FDA to reclassify a 

preamendments device. The term ‘‘new 

information,’’ as used in section 513(e) 

of the FD&C Act, includes information 

developed as a result of a reevaluation 

of the data before the agency when the 

device was originally classified, as well 

as information not presented, not 

available, or not developed at that time. 

(See, e.g., Holland Rantos v. United 

States Department of Health, Education, 

and Welfare, 587 F.2d 1173, 1174 n.1 

(DC Cir. 1978); Upjohn v. Finch, 422 

F.2d 944 (6th Cir. 1970); Bell v. 

Goddard, 366 F.2d 177 (7th Cir. 1966)). 

Reevaluation of the data previously 

before the agency is an appropriate basis 

for subsequent regulatory action where 

the reevaluation is made in light of 

newly available regulatory authority 

(see Bell v. Goddard, supra, 366 F.2d at 

181; Ethicon, Inc. v. FDA, 762 F. Supp. 

382, 389–91 (D.D.C. 1991)), or in light 

of changes in ‘‘medical science.’’ (See 

Upjohn v. Finch, supra, 422 F.2d at 

951). Regardless of whether data before 

the agency are past or new data, the 

‘‘new information’’ to support 

reclassification under section 513(e)(1) 

of the FD&C Act must be ‘‘valid 

scientific evidence,’’ as defined in 

section 513(a)(3) of the FD&C Act 

(21 U.S.C. 360c(a)(3)) and 21 CFR 

860.7(c)(2). (See, e.g., General Medical 

Co. v. FDA, 770 F.2d 214 (DC Cir. 1985); 

Contact Lens Assoc. v. FDA, 766 F.2d 

592 (DC Cir.), cert. denied, 474 U.S. 

1062 (1985)). FDA relies upon ‘‘valid 

scientific evidence’’ in the classification 

process to determine the level of 

regulation for devices. For the purpose 

of reclassification, the valid scientific 

evidence upon which the agency relies 

must be publicly available. Publicly 

available information excludes trade 

secret and/or confidential commercial 

information, e.g., the contents of a 

pending PMA. (See section 520(c) of the 

FD&C Act (21 U.S.C. 360j(c)). 

In accordance with section 513(e) of 

the FD&C Act and 21 CFR 860.130(b)(1), 

based on new information with respect 

to the device, FDA, on its own initiative, 

is reclassifying this device from class III 

to class II. 

II. Regulatory History of the Device 

As discussed in the proposed rule, the 

agency issued a final rule classifying 

this device into class III (53 FR 23856, 

June 24, 1988). In August 1997, in 

response to FDA’s order for the 

submission of information on the TOCE, 

two manufacturers submitted 515(i) 

summaries of safety and effectiveness 

information to the agency for the TOCE. 

FDA referred the 515(i) submissions to 

the General and Plastic Surgery Devices 

Panel (GPS Panel) for their 

recommendation on the requested 

reclassification. At a public meeting on 

November 17, 1998, the GPS Panel 

recommended that the device be 

retained in class III. 

Since the 1998 GPS Panel meeting, 

three studies (two prospective and one 

retrospective) reported safe use and 

adequate healing of wounds using the 

TOCE. In addition, FDA has evaluated 

more than 20 years of clinical 

experience with the device and the 

agency’s Medical Device Reports, and 

has found sufficient information to 

determine the risks to health associated 

with the use of this device and develop 

appropriate special controls. 

As a result, in the Federal Register of 

April 6, 2006 (71 FR 17390), FDA 

proposed to reclassify the TOCE device 

from class III to class II. The device is 

intended to surround a patient’s limb 

and apply humidified oxygen topically 

at a pressure slightly greater than 

atmospheric pressure to aid healing of 

chronic skin ulcers such as bedsores. 

Elsewhere in the Federal Register of 

April 6, 2006 (71 FR 17476), FDA 

announced the availability of the draft 

guidance document entitled ‘‘Class II 

Special Controls Draft Guidance 

Document: Topical Oxygen Chamber for 

Extremities,’’ which FDA intended to 

serve as the special control for this 

device type following the effective date 

of the final reclassification rule. 

Interested persons were invited to 

comment until July 5, 2006, on the 

proposed regulation and special 

controls draft guidance document. 

III. Analysis of Comments and FDA’s 

Response 

FDA received 11 comments on the 

proposed rule. The comments received 

discussed academic literature, clinical 

experiences, and patient outcomes that 

support the proposed reclassification’s 

determinations of the safety and 

effectiveness of the TOCE device. The 

comments did not recommend any 

changes to the proposed regulation. 

IV. Summary of Final Rule 

Based on the information discussed in 

the preamble to the proposed rule, the 

comments on the proposed rule, a 

review of the Manufacturer and User 

Facility Device Experience (MAUDE) 

database, and a review of current 

scientific literature, FDA concludes that 

special controls, in conjunction with 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of TOCE. The agency is, 

therefore, reclassifying TOCE from class 

III (premarket approval) into class II 

(special controls) and issuing a final 

rule that revises 21 CFR 878.5650. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Topical Oxygen 

Chamber for Extremities,’’ which will 

serve as the special control for this 

device. Following the effective date of 

this final classification rule, any firm 


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Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations 22807 

submitting a 510(k) premarket 

notification for a TOCE will need to 

address the issues covered in the special 

controls guidance. However, the firm 

need only show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurances of safety and effectiveness. 

Section 510(m) of the FD&C Act 

(21 U.S.C. 360(m)) provides that FDA 

may exempt a class II device from the 

premarket notification requirements 

under section 510(k) of the FD&C Act if 

FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of the TOCE and, therefore, this device 

type is not exempt from premarket 

notification requirements. 

V. Environmental Impact 

The agency has determined under 

21 CFR 25.34(b) that this reclassification 

action is of a type that does not 

individually or cumulatively have a 

significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VI. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action under the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the final rule 

reclassifying this device from class III to 

class II will relieve all manufacturers of 

the device of the cost of complying with 

the premarket approval requirements of 

section 515 of the FD&C Act, it will 

impose no significant economic impact 

on any small entities, and it may permit 

small potential competitors to enter the 

marketplace by lowering their costs, and 

the agency certifies that the final rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is 

$135 million, using the most current 

(2009) Implicit Price Deflator for the 

Gross Domestic Product. FDA does not 

expect this final rule to result in any 

1-year expenditure that would meet or 

exceed this amount. 

VII. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State law conflicts with the 

exercise of Federal authority under the 

Federal statute.’’ Federal law includes 

an express preemption provision that 

preempts certain State requirements 

‘‘different from or in addition to’’ certain 

Federal requirements applicable to 

devices. (See section 521 of the FD&C 

Act (21 U.S.C. 360k); Medtronic Inc., v. 

Lohr, 518 U.S. 470 (1996); Riegel v. 

Medtronic Inc., 128 S. Ct. 999 (2008)). 

The special controls established by this 

final rule create ‘‘requirements’’ for 

specific medical devices under 

21 U.S.C. 360k, even though product 

sponsors have some flexibility in how 

they meet those requirements. See 

Papike v. Tambrands, Inc., 107 F.3d 

737, 740–742 (9th Cir. 1997). 

VIII. Paperwork Reduction Act of 1995 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3520) is not required. FDA concludes 

that the special controls guidance 

document identified by this rule 

contains information collection 

provisions that are subject to review and 

clearance by OMB under the PRA. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice 

announcing the availability of the 

guidance document entitled, ‘‘Class II 

Special Controls Guidance Document: 

Topical Oxygen Chamber for 

Extremities.’’ The notice contains an 

analysis of the paperwork burden for the 

guidance. 

List of Subjects in 21 CFR Part 878 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 878 is 

amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for 21 CFR 

part 878 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Section 878.5650 is revised to read 

as follows: 

§ 878.5650 Topical oxygen chamber for 

extremities. 

(a) Identification. A topical oxygen 

chamber for extremities is a device that 

is intended to surround a patient’s limb 

and apply humidified oxygen topically 

at a pressure slightly greater than 

atmospheric pressure to aid healing of 

chronic skin ulcers such as bedsores. 

(b) Classification. Class II (special 

controls). The special control for this 

device is FDA’s ‘‘Class II Special 

Controls Guidance: Topical Oxygen 

Chamber for Extremities.’’ See § 878.1(e) 

for the availability of this guidance 

document. 

Dated: April 19, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9899 Filed 4–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[Docket ID: DoD–2011–OS–0008] 

32 CFR Part 321 

Privacy Act of 1974; Implementation 

AGENCY: Defense Security Service, DoD. 

ACTION: Direct final rule with request for 

comments. 

SUMMARY: The Defense Security Service 

is deleting an exemption rule for V5–05 

entitled ‘‘Joint Personnel Adjudication 

System (JPAS)’’ in its entirety. The 

system has been transferred to the Office 

of the Secretary of Defense. 

This direct final rule makes 

nonsubstantive changes to the Defense 


jdjones on DSKHWCL6B1PROD with RULES